CapsoAccess

Basic Information

• Brand Name: CapsoAccess
• Primary DI: 00867770000230
• Version / Model: 3
• Catalog Number: 2668
• Company Name: CAPSOVISION, INC.
• Labeler DUNS: 789635740
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-07-17
• Public Version: 9
• Public Version Date: 2020-12-10
• Public Version Status: Update
• Public Device Record Key: 41395993-fdb6-43d4-9185-27e34b346d2e

Device Description

Capsule Data Access System

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NEZ	System, Imaging, Gastrointestinal, Wireless, Capsule	Gastroenterology, Urology	876.1300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38068	Video capsule endoscopy system capsule	An electrically-powered, non-digestible capsule containing a video camera designed to pass through the gastrointestinal (GI) tract of a patient after being swallowed or endoscopically introduced, for the internal visualization and examination of the GI tract. It is intended to acquire video images of GI tract sections (e.g., oesophagus, small bowel and colon) and wirelessly transmit the images to a dedicated control unit/monitor (not included) via an external sensor array for examination and data recording. The capsule can be freely mobile or externally controlled by another device (not included); the capsule is excreted from the gut. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00867770000230	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K161773	000
K183192	000
K192662	000

Storage Conditions

• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 19 – 101 KiloPascal
• Type: Handling Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 10 – 35 Degrees Celsius
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 19 – 101 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 10 – 35 Degrees Celsius